Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure

NCT06970782 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PLB1001/PLB1004-NSCLC-III-01
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure

Conditions

Non-Small-Cell Lung Cancer

Keywords

NSCLC; Lung Cancer; MET Amplification; EGFR L858R; EGFR Exon 19 Deletion; EGFR

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) by BICR

  Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors.

  2 years

Secondary Outcomes (13)

• Progression-Free Survival (PFS) by the investigator

  2 years

• The objective response rate of the tumor (ORR)

  2 years

• Duration of Response (DoR)

  2 years

• The disease control rate (DCR)

  2 years

• Overall Survival (OS)

  3 years

Study Arms (2)

Vebreltinib 150mg BID plus PLB1004 80mg QD

EXPERIMENTAL

Subjects will receive Vebreltinib 150mg orally twice per day (BID) plus PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Drug: Vebreltinib; Drug: PLB1004

Pemetrexed plus cisplatin/carboplatin

ACTIVE COMPARATOR

Subjects randomized to the control group will receive pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first)

Drug: Pemetrexed plus Carboplatin or Cisplatin

Interventions

Vebreltinib DRUG

Subjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).

Also known as: Bozitinib, PLB1001

Vebreltinib 150mg BID plus PLB1004 80mg QD

PLB1004 DRUG

Subjects will receive PLB1004 80mg orally once per day (QD).

Also known as: Andamertinib

Vebreltinib 150mg BID plus PLB1004 80mg QD

Pemetrexed plus Carboplatin or Cisplatin DRUG

Subjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first).

Pemetrexed plus cisplatin/carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Aged at least 18 years old.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
• At least one measurable lesion as defined by RECIST V1.1.
• ECOG performance status 0 to 1.

You may not qualify if:

• There are mutations of ALK or ROS1.
• Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
• Before randomization, patients did not recover from any toxicity and/ or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] v5.0), except for hair loss and irrecoverable permanent radiation damage.
• Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
• Pregnant or nursing women.

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Liang Lin

CONTACT

+86-10-84148931; linliang@avistonebio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 14, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share